P3.1 Validation to Manufacturing

If your human factors validation study is inadequate, the FDA can bounce your entire submission back. Consequently forcing you to revise your submission file — or worse, your actual design — and [...]

Human factors validation testing shows you’ve done your due diligence to mitigate identified hazards and the resulting harms your device might cause users and patients. For the majority of [...]

Of course, you’ve been feeling the landscape shift for years. That’s why you’re already so concerned about time to market and first mover advantage. The problem is that your medical device [...]